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REG Collaborators' Meeting

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REG Collaborators' Meeting, 16th May 2015.
Denver, Colorado, USA

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REG Collaborators' Meeting

  1. 1. Saturday May 16th, 16.30-18.00 (MST) Altitude Room; Crowne Plaza, Denver, Colorado REG Interstitial Lung Disease Working Group Meeting
  2. 2. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 PCORI: New funding source for comparative effective research Followed by discussion of additional funding opportunities Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  3. 3. Richard Martin (REG North Americas Lead) 7.30-7.40am Welcome & Introductions
  4. 4. David Price (REG Chairman) 7.40-7.55am Research & Activity Update & Call for participation
  5. 5. Protocol development Data extraction Phase I (or baseline) Phase II (or results) Publication ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ 2013/14 Initiated Studies Independent risk predictors modeled; risk predictor tool in development. 1 x abstract Characteristics that predict step-up treatment choice – published. CE outcomes manuscript in print. 3 x abstracts to date Mapping of different adherence measures over 3 years – complete; bidirectional relationship between adherence & outcomes to commence 3 abstracts to date Analysis complete. Manuscript outline in development: “predictive quality of database outcomes”. 3 x abstracts Analysis complete; manuscript outline reviewed by steering committee; draft paper by June Cross-sectional analysis of comorbidities in refractory asthma patients – complete & ms written. Longitudinal analysis of comorbidities associated with os use still to be completed Collaboration with UK Department of Health. Paper published in Lancet Respiratory Medicine Diagnostic opportunities Analysis complete. Manuscript in draft; paediatric abstract presented at REG Regional Summit; Full report at EAACI 2015
  6. 6. Protocol development Data extraction Phase I (or baseline) Phase II (or results) Publication ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ COPD control 2014/15 Initiated Studies COPD Triple Therapy Protocol developed; Seeking Funding…? Final voting underway; publication to follow shortly Working group meeting tomorrow to plan protocol delivery REALISE ASIA Longitudinal Asthma Steps. Protocol developed; Funding discussions underway Proposal to item reduce and validate a reduced item EXACT- PRO. Funding under discussion Supported Asthma UK to quantify prescribing “Errors” as defined by national asthma deaths registry. 1 x abstract COPD RISK PREDITCORS: spin off of COPD eosinophils. Ms in final pre-submission stages
  7. 7. Pin board – funding awards REG CORE FUNDING TO COVER TOP 2 RANKED RESEARCH STUDIES REG CORE FUNDING TO COVER DATA EXTRACTION (ONLY) FOR FURTHER 2 HIGHLY-RANKED STUDIES
  8. 8. • Voted REG 2014 Research Pinboard: #1 priority • Lead Investigator: Jonathan Grigg • The particle size and delivery characteristics of extra-fine hydrofluoroalkane beclomethasone [EF HFA-BDP] aerosol may be particularly relevant for young children in whom a greater proportion of airways are classified as small (<2mm in diameter)1 and airways resistance is low. • There are evidence to suggestion that EF HFA BDP is equivalent to CFC fliuticasone (FP) in terms of efficacy and safety in adults and children (5–12 years) with mild-to-moderate asthma.2,3 • Evidence remains lacking as to the role that ICS particle size may play in the management of asthma/wheeze in younger, pre-school (<5 years) children. 1. Leach CL, et al. Eur Respir J. 1998;12:1346–1353. 2. Aubier M, et al. Respir Med. 2001;95:212–220. 3. Fairfax A, et al. Ann Allergy Asthma Immunol. 2001;86:575–582.
  9. 9. Aims & Objectives • Aim: to improve understanding of the prescribing of guideline recommended management approaches, and their comparative effectiveness, in the routine care of UK children with wheezing illness in their early (pre-school) years. • Phase I: a descriptive analysis of treatment patterns in children aged ≤5 years with wheezing illness • Part II: a comparative effectiveness analysis of guideline- recommended treatment options in pre-school children newly initiating Step 2 therapies: o 3 x 2-way matched comparative effectiveness analysis: EF ICS, NEF ICS and LTRA vs SABA o Relative benefit of EF ICS vs SABA over alternatives
  10. 10. Study Design Outcome Measures: • Exacerbations • Database Asthma control measures • Acute respiratory events • SABA usage Index Date: Date of first asthma / wheeze prescription Baseline year: 12-months prior to first Step 2 treatment prescription for asthma / wheeze; patient characterisation and confounder definition Secondary (exploratory) 5-year outcome period Primary 1-year outcome period EF HFA BDP Ciclesonide LTRA NEF BDP FP Eligible patients must: • Have diagnostic evidence of asthma / wheeze • be aged ≤5 years EF ICS Control NEF ICS
  11. 11. • Voted REG 2014 Research Pinboard: #2 priority • Lead Investigator: Nikos Papadopoulos; Clare Murray • Does the addition of (oral) antibiotics to oral corticosteroids in an acute asthma exacerbation offer benefit in terms of: o Time to next unscheduled GP visit with asthma; o Time to next oral corticosteroid prescription and use of SABA of the following 6 months? • Stratified by antibiotic class
  12. 12. • Voted REG 2014 Research Pinboard: #3 priority • Lead Investigator: Karin Lisspers on behalf of IPCRG’s UNLOCK • Are pharmacological RCTs relevant to real life asthma populations? • Aim: Explore to what extent are the inclusion criteria for people with asthma in RTCs representative of real life primary care populations with asthma. • Method: Compare data from primary care asthma populations at treatment step 2/3 with those meeting the inclusion criteria for the RCTs that underpin key asthma guidelines (i.e. GINA, BTS/SIGN, CTS, AAH).
  13. 13. • Voted REG 2014 Research Pinboard: #6 priority • Lead Investigator: Björn Ställberg on behalf of IPCRG’s UNLOCK • The prevalence of comorbidities in COPD patients and their impact on the quality of life and COPD symptoms in primary care patients • Aim: To enhance knowledge in terms of prevalence of comorbidities in COPD patients and their impact on the quality of life and on COPD symptoms in primary care patients. • Method: Retrospective cross sectional analysis of primary care data from different countries. Analysis will include descriptive statistics, null hypothesis tests such as Chi-Square, factorial analysis of variance and predictive binary logistic regression models.
  14. 14. Call for participation: Checklist • Delphi to develop an optimum & minimum checklist for “research-ready” databases o Optimum checklist developed in Rotterdam – wider validation required o Delphi item reduction required to confirm minimum mandatory criteria
  15. 15. Events in 2015: Rotterdam & Singapore REG 2015 Global Summit Date: 22–24 January 2015 Rotterdam REG 2015 Regional Summit Date: 25–26 April 2015 Singapore
  16. 16. Publications in 2015 • Small Airways Working Group: o Increased Dose of ICS vs. ICS/LABA for Step-Up Therapy in Asthma1 o Differential effects of ICS in smokers/ex-smokers and non- smokers with asthma2 o Small-particle ICS as first-line or step-up controller therapy in childhood asthma3 • Child Health Working Group: o Initial step-up treatment changes in asthmatic children already prescribed inhaled corticosteroids: a historical cohort study4 • Breathe Review: o Commissioned review following REG’s 2014 ERS Symposium: Real-world research and its importance in respiratory medicine.5 • REG 2015 Rotterdam Summit Abstract Book6 • ARCH Supplement now OPEN ACCESS 1Israel E, et al. Ann Am Thorac Soc 2015 Mar 10. [Epub ahead of print]; 2Roche N, et al. Am J Respir Crit Care Med 2015;191:960-964; 3Accepted at JACI: In Practice 23 Apr 2015; 4Price D, et al. Breathe. 2015;11:26-38; 5Accepted at Nature, Primary Care Respiratory Journal. 7 Apr 2015; 6Pragmatic and Observational Research. 2015; 6:13—38; 7Ann Am Thorac Soc. 2014;11:Supplement 2 ALL PUBLICATIONS ARE BEING POSTED ONLINE – VISIT THE WEBSITE FOR ON-GOING UPDATES & AUTHOR GUIDELINES
  17. 17. Symposia activity in 2015 • WAAC: April 2015 – done! • EAACI: June 2015 – 2 x sessions: o Efficacy-based to effectiveness-based guidelines in asthma: a paradigm shift? o Harnessing primary care databases to unpick the complexities of allergic obstructive airway disease • 2015 WAO & APSR session proposals – submitted! • EAACI 2016 – session accepted • ERS 2016: 3 x session proposals submitted • But First…ATS symposium this Wednesday!
  18. 18. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 PCORI: New funding source for comparative effective research Followed by discussion of additional funding opportunities Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  19. 19. David Price, Thao Le, Alison Chisholm Future Plans: staffing & events
  20. 20. Staffing: who does what? John Haughney David Price Alison Chisholm David Price Trevor Lambert Nick May Thao Le Linh Hayman Contracted as needed Mylee Durack Agency providers Contracted as needed Starting June Zoe Mitchell When David steps down as REG Chairman, we will be looking to appoint a Chair of Council… volunteers welcomed!
  21. 21. Strategic Planning Council responsible for development of an annual strategic plan. 2015 Council Planning Meeting: 25 September 2015
  22. 22. REG Support & Research Funding RESEARCH IDEA GENERATION Working Groups Identify Research Priorities in their respective fields of expertise SECURING FUNDING Nature of funding dictates future study course: • Single commercial funding source: an investigator initiated study conducted external to REG • Non-product/brand specific grant(s): an REG Collaboration carried by REG or in partnership with REG REG Supporters Non-supporter & wider institutional grants OR REG develops idea in collaboration with WG / collaborators &: (i) Seeks external support (ii) Submits for REG Core Funding Grant REG Grants awarded at FY end REG Core Grants Awarded to Top Priority Ideas (subject to available funding) Mid October Core Grant submission deadline Ideas prioritised by REG Research Committee If insufficient REG Funds, continue to look externally
  23. 23. Working Groups “At a Glance” Terms of reference drafted; initial project ideas in development IPCRG’s UNLOCK Group Inaugural Meeting at EAACI 2015 Well underway – first paper accepted in April! Inaugural Meeting in Rotterdam; Checklist Delphi & Registry Work about to commence Long-established, successful group, came under REG in 2014 Still to be established Committee Meetings Held in Rotterdam REG/EAACI Taskforce leading current activities Meeting 7-9am tomorrow Inaugural meeting 4.30- 6pm today! Pre-cursor Workshops; Second Workshop 2- 3pm today Working Group Meeting tomorrow 4-6pm Inaugural Meeting at EAACI 2015 Met in Rotterdam; study on-going & Expert (Taxonomy) Meeting at EAACI 2015
  24. 24. Events: what’s coming next…? Barcelona June 2015 First meeting of the Allergy Working Group: 2-3pm June 7th, Barcelona Working Group Lead: Peter Hellings First meeting of the Biomarkers Working Group: 5-6pm June 7th, Barcelona Working Group Lead: Leif Bjermer Adherence Expert Panel Meeting One-day focused meeting to develop a Roadmap for Respiratory Adherence Research June 11th, Barcelona Working Group Lead: Gene Colice
  25. 25. Adherence Expert Panel Meeting • International panel of experts to review key topics within respiratory adherence research. • Present and discuss key issues and challenges in adherence research • Meeting structure: o Taxonomy o Placing adherence behaviours in the context of respiratory care o Considering specific populations and topics. o Measurement – of adherence behaviours, determinants and capturing accurate data o Opportunities to improve adherence – scalable interventions with proven effect • Output: themed issue of: Adherence Roadmap
  26. 26. Events: what’s coming next…? Friday September 25th • REG Annual General Meeting immediately followed by… • REG Council Meeting (2016 strategic planning) + further working group meetings
  27. 27. Coming up… REG Summit 2016 • Dovetail 2016 Summit with final ASTROLAB symposium o Day 1: ASTROLAB o Days 2 & 3: REG WG Meetings & Summit • Venue: Lyon • Date: Late March / Early April 2016 (to avoid ATS) – Thurs- Saturday: o 30 March – 2 April o 7–9 April o 14-16 April o 21-23 April An FP7-supported Project to investigate the safety of asthma therapy, with a focus on adherence ASTROLAB: Assessment of Safety of LABAs in Asthma routine Care by Combining Healthcare Databases and Direct Patient Follow-up Compare severe exacerbations rates in patients with asthma treated by LABAs ± concomitant ICS in routine care Astrolab Meeting Attendance: 50-100 • Regulators • Scientific societies • Patients • Health Care Professionals • EU representatives • Partners and Advisory Boards
  28. 28. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 PCORI: New funding source for comparative effective research Followed by discussion of additional funding opportunities Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  29. 29. Nicolas Roche (REG European Lead) 8.05-8.20am Driving Quality Standards: REG/EAACI Taskforce Update
  30. 30. Quality initiatives: REG/EAACI Taskforce • Review of the CER asthma literature over the last 10 years • Focus on key PICOT questions that looking at “gaps” in the evidence • Development of a quality assessment tool / checklist to appraise the literature • Identify CER papers that should be considered by guideline developers • Clarify apparent contradictions in the evidence • Identify as yet unmet research needs
  31. 31. What else should we be doing? • Collaborating with other societies?
  32. 32. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 PCORI: New funding source for comparative effective research Followed by discussion of additional funding opportunities Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  33. 33. Industries view on real-world research priorities 8.20-8.35am A Word from REG’s Supporters
  34. 34. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 New funding opportunities: North American Initiatives and Grants for Implementation Science Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  35. 35. Jerry Krishnan (REG/ATS Liaison) 8.35-8.50am PCORI: New funding source for comparative effectiveness research
  36. 36. Agenda Time Item Lead 7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair) 7.40–7.55 REG Research: update & call for participation David Price 7.55-8.05 Future Plans: staffing & events update David Price, Thao Le, Alison Chisholm • Revised staffing structure: who are your key contacts? • Working Group & Council Structure: who does what? • 2015/16 Events: when will we see you next? o EAACI Events o ERS Events – AGM & Council Meeting o 2016 REG Summit 8.05–8.20 Driving Quality Standards • What else should we be doing? • ERS Vision – “Real Life Evidence” Nicolas Roche & Group Discussion 8.20–8.35 A word from REG’s Supporters invited Industry perspectives on REG activities & real-life research priorities REG supporters 8.35–8.50 New funding opportunities: North American Initiatives and Grants for Implementation Science Jerry Krishnan (Co-Chair) 8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion 9.00 CLOSE
  37. 37. All Collaborators & Attendees 8.50-9.00am Open discussion: new ideas & feedback
  38. 38. And finally…. Join these REG events TODAY TOMORROW NEXT WEEK…
  39. 39. Saturday May 16th, 16.30-18.00 (MST) Altitude Room; Crowne Plaza, Denver, Colorado REG Interstitial Lung Disease Working Group Meeting

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